Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01614717
First received: June 6, 2012
Last updated: June 25, 2014
Last verified: June 2014

June 6, 2012
June 25, 2014
July 2014
July 2016   (final data collection date for primary outcome measure)
To evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

The primary endpoint of the study is to evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months post-implant.

The symptomatic improvement is a combined endpoint defined as:

  • An improvement of at least one New Yorl Heart Association (NYHA) functional class and
  • An improvement of 10 points in the Quality of Life (QoL) Questionnaire score and
  • An increase >10% in bike exercise time in the steady state Cardiopulmonary Exercise Test (CPET).
To Evaluate the Reverse Remodeling at 12 months post Implant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary objective of the study is to evaluate the reverse remodeling due to a decrease in the LV mass (gr) associated to a reduction in resting LVOT gradient (mmHg) in hypertrophic obstructive cardiomyopathy patients with severe LVOT obstruction implanted with a CRT device at 12 months post-implant.
Complete list of historical versions of study NCT01614717 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

This investigation is a prospective, randomized, single-blinded and multicenter design.

The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac Resynchronization Therapy - Pacing (CRT-P) device.

Randomization

  • Implant will be performed (CRT-P).
  • Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular (DDD) pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12 months:
  • Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing
  • Control Group. The patient´s device is programmed to back-up pacing AAI.
  • After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD Pacing) will continue in the same group. The patients initially randomized to Control Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD Pacing). And all the patients will be followed 12 months more.

Data collection

  • In clinic Follow ups (FU): Enrollment, Baseline, Implant, Pre-discharge, 3 months (M), 12 M, 15 M and 24 M.
  • Phone call FU: 6 M, 9 M, 18 M and 21 M.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy With Obstruction
Device: CRT-P Implant
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
  • Active Comparator: Treatment Group
    CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing
    Intervention: Device: CRT-P Implant
  • Placebo Comparator: Control Group
    CRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI
    Intervention: Device: CRT-P Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
July 2018
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Unequivocal diagnosis of hypertrophic cardiomyopathy (HCM), on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness ≥15 mm) and nondilated Left Ventricle (Left Ventricle End Diastolic Diameter (LVEDD) < 55mm) confirmed by a Core Lab Echo (Appendix I).
  2. Significant resting (not provoked) LV outflow tract obstruction, on the basis of peak LVOT gradient ≥50 mmHg, estimated by continuous wave Doppler and confirmed by a Core Lab Echo (Appendix I).
  3. Presence of refractory symptoms (exertional dyspnea or chest pain) despite of optimal treatment with betablockers and/or verapamil for at least 3 months (NYHA class >II).
  4. Patients that refuse or have contraindication for septal myectomy or septal ablation (i.e., comorbidity, inappropriate coronary anatomy for septal ablation) or prefer cardiac pacing.
  5. Patients that are at high risk for developing heart block following septal myectomy or septal ablation.
  6. Patient's age is 18 years or greater.
  7. Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form.
  8. Patients must be willing and able to comply with all study requirements.

Exclusion Criteria:

  1. Known causes of cardiac hypertrophy as infiltrative cardiomyopathy, aortic stenosis and severe uncontrolled hypertension.
  2. Permanent or persistent atrial fibrillation.
  3. Previous septal myectomy or septal ablation.
  4. Any indication for permanent pacing, except for HOCM.
  5. Any indication for an Implantable Cardioverter Defibrillator (ICD).
  6. Systemic disease that would preclude completion of the protocol.
  7. Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical).
  8. Patients with a life expectancy <24 months (based on investigator assessment).
  9. Patients who are or may potentially be pregnant.
Both
18 Years and older
No
Spain
 
NCT01614717
CR-11-030-EU-HF
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Josep Brugada, Proffesor Hospital Clinic I Provincial, Barcelona, Spain
Principal Investigator: Antonio Berruezo, Dr. Hospital Clinic I Provincial, Barcelona, Spain
St. Jude Medical
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP